
Product
BGC20-0582
Indication
Head lice
Phase
Phase II
Description
BGC20-0582 is a non-pesticidal product derived from a natural botanical source in development for the treatment of head lice infestation. BTG has developed a proprietary gel-based formulation for use as a topical treatment. A US Phase II trial investigating the safety, tolerability and efficacy of BGC20-0582 for the treatment of head lice infestation was completed in early 2008. BGC20-0582 was well tolerated. The calculated efficacy rate compared favourably to a leading over-the-counter product in studies of similar design and patient demographic.
Further Information
In laboratory studies, BGC20-0582 exhibited both pediculicidal (lethal to lice) and ovicidal (lethal to eggs) properties following very short treatment times. In these same studies, BGC20-0582 was shown to be superior to a leading over-the-counter lice treatment product. BGC20-0582 appears to work through multiple mechanisms of action that are distinct from those associated with the currently available lice treatment products, most of which are pesticide based. These unique modes of action suggest that BGC20-0582 may be less susceptible to the drug resistance that is increasingly limiting the effectiveness of currently marketed lice treatment products.
Head lice, Pediculus humanus capitis, are parasites which live on human hair shafts. Head lice are spread by head-to-head contact, and infestation is most common among children in childcare centres and schools. The annual incidence of head lice infestation in the United States is between six and twelve million with the majority of those infested being school age children. This incidence of infestation results in an estimated 12 to 24 million missed school days per year. In developing countries it is estimated that over 50 per cent of the general population may be infested. Head lice infestation can cause intense scalp itching and irritation. The American Academy of Pediatrics has provided guidelines that strongly recommend the use of currently available over-the-counter treatments as first line treatment for head lice infestation. However, many of these over-the-counter therapies are ineffective treatment options because of the emergence of lice resistance. There is a growing need for new safe and effective treatments for the treatment of head lice infestation.
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